Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
  • A61B17/3421—Cannulas
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3498—Valves therefor, e.g. flapper valves, slide valves
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/34—Trocars; Puncturing needles
  • A61B17/3462—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals
  • A61B2017/3464—Trocars; Puncturing needles with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals with means acting on inner surface of valve or seal for expanding or protecting, e.g. inner pivoting fingers
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
  • A61M39/02—Access sites
  • A61M39/06—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof
  • A61M2039/0626—Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof used with other surgical instruments, e.g. endoscope, trocar

Definitions

• the present invention pertains to medical instruments and, more particularly, to a valve assembly for providing a variable size passage in an endoscopic portal to prevent fluid through the portal while allowing implements of various sizes to be selectively introduced through the valve.
• an endoscopic portal such as a sleeve or cannula
• an anatomical cavity wall to provide a passage for insertion of medical instruments frequently required that the passage be sealed to prevent the flow of fluids through the endoscopic portal.
• many medical procedures gain access to an anatomical cavity by utilizing a penetrating member, such as a trocar, obturator or needle, having a sharp penetrating tip for puncturing the cavity wall to establish communication with the interior of the anatomical cavity.
• a sleeve or cannula is then left in situ for utilization as a portal to introduce medical instruments into the anatomical cavity.
• the portal must be sealed prior to and subsequent to the introduction of any instruments and while such instruments are in place.
• fluids such as gaseous phase carbon dioxide or nitrous oxide
• fluids such as gaseous phase carbon dioxide or nitrous oxide
• a valve that has a single, particular size passage dependent upon the penetrating member.
• additional instruments to be introduced into the anatomical cavity through the passage may be of diverse types and sizes and it will be appreciated that fluid can escape past smaller instruments.
• a penetrating member is usually received within a portal sleeve that passes through the wall of an anatomical cavity with the penetrating member and remains in place to establish communication with the interior of the cavity after the penetrating member has been removed from the sleeve.
• the sleeve typically has a proximal end secured in a housing provided with a valve that allows the penetrating member to be inserted into the sleeve. The valve prevents the flow of fluids to and from the anatomical cavity and closes when the penetrating member is removed from the sleeve.
• the size of the penetrating member utilized varies depending upon the procedure and the type of anatomical cavity to be penetrated. Once the penetrating member has been removed from the sleeve, a great variety of instruments of various sizes and diameters are introduced into the anatomical cavity via the portal dependent upon the procedure to be performed.
• Prior art endoscopic portals utilize a valve, such as a flapper or gate valve, that is normally biased to a closed position but in an open position has a passage or lumen therethrough of only a single size. Accordingly, such endoscopic portals suffer from the disadvantages of allowing the passage or leakage of fluids when surgical instruments smaller than the single passage are introduced therethrough or of limiting the implements to be used in a procedure to a single size. Additionally,, such endoscopic portals can be effectively used with only a single size penetrating member.
• Another object of the present invention is to define multiple lumens or passages of diverse sizes in a valve assembly for an endoscopic portal to selectively produce a sealing relation with medical instruments of various sizes.
• a further object of the present invention is to utilize a valve assembly to normally seal an opening or passage through an endoscopic portal and to permit medical instruments of diverse sizes to be introduced through the opening or passage while preventing fluid flow or leakage.
• Some of the advantages of the present invention over the prior art are that a complete endoscopic procedure can be performed with a single portal thereby reducing instrument costs and surgery time, a single endoscopic portal can be used with various sizes and types of penetrating members, and the endoscopic portal can be inexpensively manufactured to be economically disposable for single patient use.
• the present invention is generally characterized in an endoscopic portal including a tubular sleeve or cannula having an open distal end for positioning within an anatomical cavity, an open proximal end for positioning externally of the anatomical cavity, and a valve assembly disposed at the open proximal end of the sleeve for controlling fluid passing therethrough.
• the valve assembly includes a spherical valve body defining a plurality of different size lumens or passages that can be selectively aligned with the open proximal end of the sleeve.
• the valve body is rotatably carried in a valve housing mounting the proximal end of the sleeve and is preferably biased toward a position closing a passage formed through the valve housing.
• Another aspect of the present invention is generally characterized in a method of forming a portal in the wall of an anatomical cavity by selectively rotating a spherical valve body within a valve housing to align a first passage formed in the valve body with the open proximal end of a portal sleeve mounting the valve housing, inserting a penetrating member through the passage and sleeve, penetrating the anatomical cavity wall with the penetrating member and portal sleeve, withdrawing the penetrating member from the sleeve, selectively rotating the valve body to align a second passage formed in the valve body with the open proximal end of the portal sleeve, and inserting a medical instrument through the valve body and sleeve to access a site within the anatomical cavity.
• Figs. 2 is a partial sectional view .taken along line 2- 2 of Fig. 1.
• Fig. 3 is a broken top view of the endoscopic portal of Fig. l.
• Fig. 4 is a broken side view of the endoscopic portal of Fig. 1.
• Figs. 5 - 10 are partial sectional views taken along line 2-2 in Fig. 1 and illustrating various valve positions.
• Fig. 11 is a broken top view of another endoscopic portal according to the present invention.
• the endoscopic portal of the present invention is described hereinafter for use as an instrument for inserting a portal sleeve through a wall of an anatomical cavity to form a portal for the introduction of various surgical and diagnostic instruments into the cavity during endoscopic procedures, such as laparoscopy. It is understood, however, that the endoscopic portal of the present invention can be used for introduction into anatomical cavities of needles with fluid flow therethrough and catheters as well as for other instruments engaging tissue during surgical or diagnostic procedures. Accordingly, the cannula or outer tubular member of the endoscopic portal can be a portal sleeve, a needle, a catheter or a tubular component of a medical instrument.
• the endoscopic portal 10 includes a tubular, cylindrical sleeve or cannula 20 for positioning through the anatomical cavity wall during the penetration to provide access to a site within the anatomical cavity.
• the sleeve 20 has a tapered, open distal end 22 adapted to be disposed within the anatomical cavity and an open proximal end 24 adapted to be disposed externally of the body.
• the proximal end 24 is externally threaded to engage internal threads at the forward end of a housing 26 to couple the housing with the proximal end of the sleeve.
• Housing 26 has an enlarged forward flange 28 joined to a tubular end 30 that is internally threaded for receiving the proximal end 24 of sleeve 20.
• a pair of spaced, parallel side walls 32 and 34 extend from forward flange 28 and connect with an enlarged rear flange 38.
• a valve block 36 is received within the housing 26 and is closely fitted between side walls 32 and 34.
• Block 36 includes a proximal face 39 parallel to rear flange 38 and a tapered distal face 40 positioned adjacent tubular end 30.
• a longitudinal passage 42 is defined through the housing including an opening in flange 38 and a bore through block 36 in longitudinal alignment with the longitudinal axis of sleeve 20, and implements such as penetrating member 14 can be inserted into the sleeve 20 via the passage 42.
• a spheroidal cavity 44 is formed in block 36 and centered along the longitudinal axis of the sleeve 20 and the passage 42.
• a spherical valve body 46 is disposed in cavity 44 and is freely rotatable about a plurality of axes.
• a plurality of different size passages or lumens 47, 48, 49, 50, 51 and 52 are formed in valve body 46 diametrically with respect to the center of the valve body.
• Lumens 47, 48, 49, 50, 51 and 52 have longitudinal axes contained in a plurality of planes intersecting the center of the valve body 46.
• the lumens 47, 48, 49, 50, 51 and 52 are angularly spaced from each other and form a generally ring-shaped configuration of openings on the surface of the valve body 46.
• the spacing between lumens 47, 48, 49, 50, 51 and 52 is selected to provide a solid surface 54 on the valve body large enough in size to cover and seal passage 42 when the solid surface 54 is aligned with passage 42 by rotation of the valve body.
• Lumens 47, 48, 49, 50, 51 and 52 are of different size or diameter; and, as shown, lumen 47 is the largest diameter passage, lumen 48 is the next largest diameter passage, and so on, with lumen 52 being the smallest diameter passage
• valve block 36 surrounds only a central portion of valve body 46 so that upper and lower portions 56 and 58 of the valve body 46 project out of the valve block 36.
• Housing 26 includes a top wall 60 connecting the side walls 32 and 34 and the forward and rear flanges 28 and 38 of the housing and forming a hemispherical dome 62 spaced radially from the protruding upper portion 56 of the valve body 46 to define a small gap therebetween.
• a bottom wall 64 connects between side walls 32 and 34 and forward and rear flanges 28 and 38 to form a lower hemispherical dome 66 sealingly engaging the lower protruding portion 58 of the valve body 46. As best seen in Figs.
• a plurality of slotted openings 68, 70, 72, 74, 76 and 78 corresponding in number to the number of lumens or passages formed in the valve body 46, are formed in the upper hemispherical dome 62 and extend radially from a common center 73.
• a handle 80 including a knob 82 mounted on a shaft 84 secured to the valve body 46 extends through the slotted openings 68, 70, 72, 74, 76 and 78 and is movable along the slotted openings to rotate the valve body 46 to a number of predetermined locations for aligning different luminal passages with the longitudinal passage 42.
• a bias element 86 shown as an elastic membrane 88 in Fig.
• the elastic membrane 88 is formed of rubber, or any other resilient material, and includes a generally hemispherical portion 90 surrounding the shaft 84 and a peripheral lip or rim 92 secured between the valve block 36 and the top wall 60 of the housing 26.
• an implement such as penetrating member 14 having a size corresponding to the size of the aligned lumen can be inserted into the opening in flange 38 to extend through the aligned lumen of the valve body and sleeve 20. Since the aligned lumen corresponds to the size of the inserted implement and the valve body 46 is sealingly received in block 36, the passage of fluids through the housing and valve assembly is prevented. The valve assembly therefore, permits diverse surgical instruments to be inserted into the sleeve with a single portal in a manner maintaining a sealed environment.
• handle 80 When utilized in conjunction with penetrating member 14, handle 80 is grasped and moved along slotted opening 68 to rotate valve body 46 into the position shown in Figs. 1 and 2 to align lumen 47 corresponding in size and cross- sectional shape with penetrating member 14 to provide sealing engagement therebetween.
• the distal end 16 of penetrating member 14 is inserted into the housing 26 through the opening in flange 38 to extend through passage 42, lumen 47 and sleeve 20 such that distal end 16 projects from the distal end 22 of the sleeve.
• a pneumoperitoneum will have been created, for example with the use of a Varres needle.
• the penetrating member When a solid penetrating member, such as the trocar shown, is forced through the anatomical cavity wall, the penetrating member will function as an obturator and escape of gas from the peritoneum will be prevented due to the seal between the penetrating member and the valve assembly.
• the penetrating member is hollow, such as a needle, the proximal end 18 will be closed to prevent passage of fluid therethrough. If no pneumoperitoneum has been created prior to insertion of the penetrating member, insufflation can be accomplished via a valve, not shown, in the proximal end of the needle 18.
• Valve body 46 can now be rotated using handle 80 to align the same or a different lumen with passage 42 to allow the same or a different sized medical instrument to be inserted therethrough for introduction via the sleeve to the site within the anatomical cavity. More particularly, if handle 80 is moved to a terminal end of slotted opening 74, valve body 46 will assume the position shown in Fig.
• valve body 46 will assume the position shown in Fig. 7, and lumen 51 will be aligned with passage 42; if handle 80 is moved to a terminal end of slotted opening 78, valve body 46 will assume the position shown in Fig. 8, and lumen 52 will be aligned with passage 42; if handle 80 is moved to a terminal end of slotted opening 70, valve body will assume the position shown in Fig. 9, and lumen 48 will be aligned with passage 42; and, if handle 80 is moved to a terminal end of slotted opening 72, valve body 46 will assume the position shown in Fig. 10, and lumen 49 will be aligned with passage 42.
• indicia 94 on the housing wall 60 in combination with handle 80 which can act as a pointer or indicator, accurate alignment of the lumen with passage 42 through the valve assembly, housing and sleeve can further be assured. Consequently, hemispherical dome 62 of housing wall 60 can be removed as indicated by phantom line in Figs. 2 and 3, leaving an opening 96 through which elastic membrane 88 protrudes, and alignment of the lumen with the passage through the valve assembly can be confirmed solely by reference to the position of handle 80 relative to indicia 94.
• the number of different size lumens or passages in the valve assembly and the sizes thereof are dependent upon the instruments to be used in the endoscopic procedure to be performed and the diameter of the valve body. For example, frequently used instruments commonly have diameters ranging in size from 1mm to 20mm in lmm increments; and, thus, lumens corresponding to these diameters are preferred. Although six lumens have been illustrated as being formed in valve body 46, it will be appreciated that fewer or more lumens could be formed depending on the relative sizes of the valve body and the lumens, and that the slotted openings would then be configured accordingly to permit rotation of the valve body to align those lumens with the longitudinal passage 42. For example, in Fig.
• top wall 60 of the housing 26 defines a plurality of jagged slots 98, 100, 102, 104, 106 and 108 for accessing more than one valve body rotational position. Movement of handle 80 along individual straight segments of the jagged slots aligns a different lumen with passage 42.
• the top wall 60 also defines a pair of arcuate slots 110 and 112 for rotating the valve body out of the closed position; it being understood that if the arcuate slots 110 and 112 were straight instead of curved, movement of handle 80 along the slots would merely cause valve body 46 to rotate about the longitudinal axis of the sleeve and would thus keep the solid surface 54 of the valve body centered on the passage 42 thereby maintaining the valve assembly 12 in the closed position.
• handle 80 disposed centrally or within a slotted opening, it is possible to rotate the handle 80 about the longitudinal axis of the shaft 84 to turn the valve body as shown in Fig. 12 to successively align lumens 114, 116 and 118 formed along the rotational path of the body.
• the entire surface of the valve body can be utilized for defining lumens except that portion of the sphere used for covering the longitudinal passage 42 in the closed position.
• Accurate alignment of the lumen with passage 42 when rotation of the handle 80 is permitted can further be assured by use of indicia 120 on the handle 80 in combination with the indicia 94 on the housing wall 60. If, however, rotation of the handle 80 is not needed or desired, handle 80 can be restrained from rotating by securing the handle shaft 84 to the bias element 86 in such a manner to prevent rotation of the handle 80.
• the endoscopic portal of the present invention can be used for engaging medical instruments of various sizes in sealing relation to prevent fluid flow therethrough while allowing the medical instruments to be introduced into an anatomical cavity and removed in succession during a procedure.
• the valve assembly of the present invention can be used in combination with known flapper valves, elastic seals and the like mounted in the housing to provide added protection against leakage, but is particularly advantageous when used alone in order to reduce the overall size of the portal.
• the components of the endoscopic portal can be made of any suitable, medical grade materials to permit sterilization for reuse or for single patient use and can be made of multiple parts of various configurations and materials to reduce cost.
• the valve body can be solid or hollow, spherical, spheroidal or oblate, or any combination thereof, and can be made of separate parts as in a perforated shell surrounding a spherical or non-spherical member such as a tube.
• the bias member for returning the valve body to the closed position can be an elastic membrane as shown or any other resilient member or mechanism, including helical coil springs, leaf springs, elastic cords and bands or magnets.
• the valve body can be automatically or manually locked in one or more predetermined positions aligning a lumen with the longitudinal passage by, for example, utilizing detents that engage the body and are released either manually or in response to withdrawal of the medical instrument from the lumen and/or housing.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Heart & Thoracic Surgery (AREA)
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• Animal Behavior & Ethology (AREA)
• Biomedical Technology (AREA)
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• Pathology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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• 1994
  • 1994-08-02 US US08/285,636 patent/US5478318A/en not_active Expired - Fee Related
• 1995
  • 1995-08-02 WO PCT/US1995/009494 patent/WO1996004039A1/en not_active Application Discontinuation
  • 1995-08-02 EP EP95927494A patent/EP0773812A4/de not_active Withdrawn
  • 1995-08-02 AU AU31510/95A patent/AU680380B2/en not_active Ceased
  • 1995-08-02 CA CA002196581A patent/CA2196581A1/en not_active Abandoned
  • 1995-08-02 JP JP8506616A patent/JPH10503401A/ja active Pending

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